MAUDE Adverse Event Report: MEDEFIL, INC HEPARIN LOCK FLUSH SOLUTIONS, USP 500 UNITS/5 ML; HEPARIN, VASCULAR ACCESS FLUSH

Model Number NOT APPLICABLE

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 12/22/2021

Event Type  malfunction  

Manufacturer Narrative

Medefil investigated event.Details of the investigation are given in the attached 'attachment to the mdr report'.After side by side evaluation of both products, we found that the dispenser box with corresponding label of both products can be easily differentiated.Heparin lock flush solution dispenser box label is yellow in color whereas the normal saline i.V.Flush syringe dispenser box label is white in color.2d barcode and track and trace information can easily differentiate what product, lot number and expiration date is contained in the box.Medefil has been marketing heparin lock flush solution and normal saline i.V.Flush syringes in these dispenser boxes since 2005 and have marketed more than 1 billion syringes (more than 16 million dispenser boxes) till date.This is the first complaint we have received for the dispenser box packaging of our flush syringes.Based on the differences noted above, both products can be easily differentiated from each other; therefore, these should be no potential for improper product selection or use of the flush solutions.

Event Description

As per mdr, on (b)(6) 2021, the reporter states that the boxes of medefil's heparin lock flush, 500 units/5 ml and normal saline i.V.Flush syringe looks identical.He notified their receiving staff and posted safety announcement for this to all staff.Event reported by the reporter to fda via medwatch.

• Brand Name: HEPARIN LOCK FLUSH SOLUTIONS, USP 500 UNITS/5 ML
• Type of Device: HEPARIN, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): MEDEFIL, INC; 250 windy point dr; glendale heights IL 60139
• Manufacturer (Section G): MEDEFIL, INC.; 250 windy point drive; glendale heights IL 60139
• Manufacturer Contact: pradeep aggarwal ; 250 windy point dr; glendale heights, IL 60139 ; 6306824600
• MDR Report Key: 15242328
• MDR Text Key: 303404706
• Report Number: 1423982-2022-00004
• Device Sequence Number: 1
• Product Code: NZW
• UDI-Device Identifier: 6425333335
• UDI-Public: 64253-333-35
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092491
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1